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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

37,779 Total Recalls

IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.

Siemens Healthcare Diagnostics

Class I - Dangerous

Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result

Nov 4, 2022 Diagnostic Equipment Nationwide View Details →

HENRY SCHEIN, ENT SET UP PACK, Item No.570-2742

Stradis Medical, LLC

Class I - Dangerous

Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

Nov 2, 2022 Other Medical Devices Nationwide View Details →

HENRY SCHEIN, Vein Clinics 1, Item No.570-1426

Stradis Medical, LLC

Class I - Dangerous

Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

Nov 2, 2022 Other Medical Devices Nationwide View Details →

HENRY SCHEIN, RHINO PACK, Item No.570-3070

Stradis Medical, LLC

Class I - Dangerous

Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

Nov 2, 2022 Other Medical Devices Nationwide View Details →

HENRY SCHEIN, Amnio Tray, Item No.570-3059,

Stradis Medical, LLC

Class I - Dangerous

Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

Nov 2, 2022 Other Medical Devices Nationwide View Details →